Impact of Spinal Curves on Asymmetric Posture in Idiopath... | NCT06733623

Studies
Impact of Spinal Curves on Asymmetric Posture in Idiopathic Scoliosis

NCT06733623

Sponsor

Istituto Scientifico Italiano Colonna Vertebrale

Status

Active, not recruiting

Last Update Posted

Dec 13, 2024Actual

Enrollment

490Estimated

Phase

Not provided

Conditions

Adolescent Idiopathic Scoliosis (AIS)
Juvenile Idiopathic Scoliosis

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 10, 2024Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Jun 2026Estimated

First Submitted Date

Dec 10, 2024

First Submission Date that Met QC Criteria

Dec 10, 2024

First Posted Date

Dec 13, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2024

Last Update Posted Date

Dec 13, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Asymmetric postures are often observed in patients with adolescent idiopathic scoliosis (AIS) and are partially associated with instability in sitting and standing positions, as well as with imbalances in gait kinematic parameters in cases of moderate or severe scoliosis.

Based on the currently available data, no correlation has been identified between habitual postures in daily life and the presence of scoliosis. However, the asymmetry of preferred postures in relation to the morphological characteristics of the curves, and how this might contribute to the progression of the clinical condition due to prolonged uneven load distribution, has not yet been analyzed.

Understanding any preferential direction in postures habitually adopted by patients with idiopathic scoliosis could provide valuable insights for the conservative management of the condition.

The aim of this study is to analyze the influence of the morphological characteristics of scoliotic curves (type and laterality) in patients with juvenile and adolescent idiopathic scoliosis on the choice of preferentially maintained asymmetric postures in daily life, using a descriptive questionnaire completed by family members and caregivers, compared to a group of non-scoliotic subjects.

Evaluate the effect of curve magnitude, age, sex, and Risser grade on the choice of usual asymmetric postures.

Estimate the impact of prolonged maintenance of habitual asymmetric postures on the clinical progression in patients with juvenile and adolescent idiopathic scoliosis

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

490Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Scoliosis patients		Patients aged between 6 and 18 years old with a diagnosis of idiopathic scoliosis are asked to answer a questionnaire investigating the preferred postures adopted daily
Control group		Subjects aged between 6 and 18 years old without a diagnosis of idiopathic scoliosis are asked to answer a questionnaire investigating the preferred postures adopted daily

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Everyday posture questionnaire	The types of postures most frequently maintained in daily life by patients with idiopathic scoliosis will be compared with a group of age-matched individuals without scoliosis, and any statistically significant differences will be analyzed using the chi-square test	At enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Scoliosis group:

Inclusion Criteria:

Diagnosis of juvenile or adolescent idiopathic scoliosis;
Age between 6 and 18 years;
Full spine X-ray in a standing position with anteroposterior projection performed within the year prior to completing the questionnaire.

Exclusion Criteria:

Diagnosis of secondary scoliosis
Patients with neuromotor control disorders

Control group:

Inclusion criteria:

Age between 6 and 18 years;
No diagnosis of sciolisis
Full spine X-ray in a standing position with anteroposterior projection performed within the year prior to completing the questionnaire.

Exclusion Criteria:

- Patients with neuromotor control disorders

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

The participants of the study are patients of a tertiary referral outpatient clinic specializing in the conservative treatment of spinal deformity

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
ISICO		Milan	Italy	20141	Italy

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Anonymized data will be uploaded on a public repository (Zenodo)

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided